In pursuit of that goal, he plans to link reimbursement data from Medicare prescription drug plans (PDPs) with existing Medicare hospitalization and physician-care databases. The result will be an unprecedented collection of data on the prescription drug use of millions of elderly patients. Both as a tool and a challenge for pharma, Medicare's new knowledge base promises to have a major impact on the industry.
Identifying drug adverse events Medicare already provides FDA with information related to safety issues that emerge for those drugs covered by Medicare Part B, such as data on what kinds of patients use a certain treatment and possible long-term complications. Integrated outpatient drug use data will help identify drug safety issues more broadly, which may involve rare but potentially important adverse events. This could enhance FDA post-market surveillance activities by reducing reliance on spontaneous reporting of adverse events by healthcare providers. McClellan anticipates that FDA will be able to determine much more quickly if certain drugs are associated with important complications in particular kinds of patients. Drug manufacturers and prescribers ideally will use such information to target drugs to patients who don't have such side effects, and may truly benefit.
Assessing off-label risks and benefits Medicare drug information can provide evidence for marketers seeking to expand indications. Utilization and safety data may better answer questions involving subpopulations with different demographics, co-morbidities, risk factors, and baseline therapeutic regimens than those studied in clinical trials. The flip side, of course, is that Medicare data may reveal negative side effects and added risks from off-label use.
Comparing treatment costs and effectiveness Part D data combined with other health information will help determine whether certain medication management techniques or treatment approaches lead to best results and lower costs for certain types of patients. McClellan envisions studies to show » which drugs keep patients with complex diseases out of hospitals or how certain treatments can reduce side effects. Such analysis, which would be conducted by outside experts and research organizations, would support decisions on best practices in using medications to improve outcomes and lower overall costs of care.